The pharmaceutical industry is faced with increasing legislation and guidance on efficacy, quality, and safety during the entire life cycle of their products. Quality and compliance departments in the sector are expected to control compliance of the entire pharmaceutical supply chain, from incoming goods to the delivery of final product to the patient.

In addition, governments in emerging markets are tightening regulations for the pharmaceutical industry in their countries. This brings suppliers more in line with what is accepted as GMP compliance in Europe and North America and gives these suppliers a valuable head start against their competitors as they vie for business from drug companies.

SGS can provide a wide range of Good Manufacturing Practices Audit / GMP Audit services to both drug manufacturers and suppliers in the pharmaceutical supply chain.

• Manufacturers of Active Pharmaceutical Ingredients (APIs)
• Suppliers of Active Pharmaceutical Ingredients (APIs)
• And manufacturers of raw materials and supplies
• Pharmaceutical companies, the marketing authorization holders

Read our Pharma GMP Audit Solutions Brochure

(PDF 301 KB)

SGS services Include:

• Compliance auditing of manufacturers -second- and third- party
  • Active Pharmaceutical Ingredients - APIs
  • Non-Active substances -excipients
  • Other raw materials and supplies
    
    
• Training of quality management departments
  
  
• Gap-auditing of pharmaceutical companies and third party suppliers by assisting during self-inspections to reflect on the company’s internal Quality Management System
  
  
• Technical advisory services for the quality organization of drug companies and its suppliers.

Case Study: European Drug Company Uses SGS to Monitor Compliance in Asia

A European based drug company needed to monitor the compliance of one of their active pharmaceutical ingredients (API) suppliers in Asia. The drug company turned to SGS to verify the actual quality status of the API supplier, which SGS performed during a two-day GMP audit of the supplier against the accepted and harmonised global standard for API manufacturers, ICH Q7A. The drug company was able to use the SGS audit report to their advantage during a standard regulatory agency inspection.

• Learn more about the Pharma GMP Audit Solutions Toolkit.
• View the technical bulletin on GMP Auditing for the Pharmaceutical Industry (PDF 53.5 KB)
• Read why SGS is the ideal partner for your Pharmaceutical GMP Audit Solutions needs.